Process Engineer MS&T

System One; Princeton (NJ); On-site; USD 68,000 - 97,000; Part time

Benefits offered by this job

Health benefits and 401(k) plan

On-site work

Job summary

System One, Inc. seeks a Process Engineer MS&T for contract-to-hire at its Princeton, NJ site. The role provides on-site manufacturing process support, tech transfer, and CAPA ownership, with responsibility for batch records, SOPs, and regulatory compliance.

The candidate should have a BS or higher in science or chem/biomedical engineering, 5+ years in GMP biologics or cell therapy manufacturing, and strong knowledge of cGMP and 21 CFR parts. The position offers up to $60/hour.

Qualifications

• BS degree or Advanced degree in Science or Chem/Bio Engineering.
• Minimum 5+ years of industry experience.
• Minimum 3+ years GMP biologic/cell therapy manufacturing process support.
• Scientific understanding in bioprocessing principles.
• Familiarity with cell therapy processes and cGMP.
• Experience with equipment qualification and validation strategies and methodologies.
• Understanding of 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations.
• Experience interfacing with clients and cross-functional teams.
• Experience with startup/validation/licensure of new biopharmaceutical manufacturing facilities is a plus.
• Experience with data aggregation, processing and analysis software is a plus.

Responsibilities

• Serve as technology and process SME on the floor.
• Provide on-the-floor and on-site technical support to manufacturing.
• Author, review and approve batch records and SOPs.
• Author and approve protocols and reports per regulatory expectations.
• Analyze and summarize manufacturing data for impact assessments and investigations.
• Own change controls for process and procedure changes.
• Lead CAPA system investigations.
• Lead tech transfer for new processes and product implementation.
• Perform tech transfer facility fitness, gap analysis, and risk assessments.
• Apply continuous improvement tools to close procedural and compliance gaps.
• Identify opportunities for process improvements and lead implementation.
• Interface with Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities; review qualification docs; draft URS; participate in impact assessments.
• Perform gowning activities and enter manufacturing plant.

Skills

Bioprocessing principles

cGMP

Data analysis

GMP manufacturing

Equipment qualification

21 CFR Part 11 familiarity

Client interfacing

Cross-functional collaboration

Education

Bachelor's or Advanced degree in Science or Chem/Bio Engineering

Tools

Data Historian

Distributed Control Systems

Statistical software

Program management software

Job description

Job Title: Process Engineer MS&T
Location: Princeton, NJ
Type: Contract To Hire
Work Model: Onsite
Hours: Mon-Fri; 8am-4:30pm
Compensation: up to $60 per hour pending overall experience

Responsibilities

• Functions as a technology and process subject matter expert.
• Provides on-the-floor and on-site technical support to manufacturing when necessary.
• Author, review and approve, as needed, various documents (e.g. Batch records, SOPs).
• Author, and approve protocol and reports in accordance with internal and external regulatory expectations (APS, Engineering, Tech Transfer).
• Analyze and summarize manufacturing data to support impact assessments and investigations.
• Owner of change controls for process and procedure changes.
• Lead and executes CAPA system investigations
• Leads technology transfer efforts for new processes and product implementation.
• Performs tech transfer facility fitness, gap analysis, and risk assessment when on-boarding new programs.
• Applies continuous improvement tools to identify and close procedural and compliance gaps
• Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts.
• Represent MSAT and interface with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering.
• Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirement specifications, and participating on impact assessments.
• Ability to perform gowning activities and enter the manufacturing plant

Requirements

• BS degree and/or Advanced degree in Science or Chem/Bio Engineering
• Minimum 5+ years of industry experience.
• Minimum 3+ years relevant experience in GMP biologic/cell therapy manufacturing technical or process support
• Scientific understanding in bioprocessing principles
• Familiarity with cell therapy processes and cGMP
• Exp. in equipment and process qualification and validation strategies and methodologies
• Demonstrated understanding of Title 21 CFR Part 11 and 21 CFR Parts 210 and 211 cGMP regulations, including their application to cGMP facilities, personnel training, equipment, materials, records, documents, manufacturing processes, packaging, and labeling
• Experience working with external parties and/or cross-functional teams
• Experience interfacing with clients
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities is a huge plus
• Experience with program management software and tools are a plus
• Experience with data aggregation, processing and analysis software and tools and/or statistical software applications is a plus
• Experience with Data Historian and Distributed Control Systems is a plus

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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Ref: #558-Scientific